FDA Drug Approval: A Black and White Issue?

Abstract

The FDA should judiciously limit the FDA approval of race-specific drugs to situations in which the utilization of racial categories is based on statistically significant scientific data and necessity and, in such cases, the meaning of race utilized should be defined. The term “race†is an inherently ambiguous social construct making the FDA approval of race-specific drugs and use of race in FDA approval decisions dangerous with debatable scientific legitimacy. Further, race is generally used in drug trials as a crude proxy for the determination of genetic variation, which tends to be both over and under-inclusive in determining the efficacy or safety of a drug for any individual. The limited genetic validity of race is confounded by the reality that many population differences between races may be the result of socio-economic and environmental factors that are not per se innate or inherent to any racial population. While the scientific validity of race as biologically significant classification is debatable, the general public is likely to interpret the governmental approval of the drug by the FDA as evidence of inherent genetic differences between racial groups that will serve to only further racial discrimination and eugenic ideologies. Thus, the FDA should proceed cautiously by narrowly tailoring the use of race in the FDA approval of new drugs and require a showing of statistically significant scientific data and the need to rely on race because of the lack of genetic markers.